US6039728A - Working shaft for photo-thermal therapy - Google Patents

Working shaft for photo-thermal therapy Download PDF

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Publication number
US6039728A
US6039728A US08/313,256 US31325694A US6039728A US 6039728 A US6039728 A US 6039728A US 31325694 A US31325694 A US 31325694A US 6039728 A US6039728 A US 6039728A
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United States
Prior art keywords
working shaft
fluid
distal end
shaft system
scattering
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
US08/313,256
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English (en)
Inventor
Hans-Peter Berlien
Gerhard Muller
Jurgen Beuthan
Carsten Philipp
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LASER-UND MEDIZIN TECHNOLOGIE GGMBH BERLIN
Biolitec AG
Huttinger Medizintechnik GmbH
Ceram Optec GmbH
Huttinger Medizintechnik GmbH and Co KG
Original Assignee
Huttinger Medizintechnik GmbH
Ceram Optec GmbH
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Priority claimed from DE19924211526 external-priority patent/DE4211526A1/de
Application filed by Huttinger Medizintechnik GmbH, Ceram Optec GmbH filed Critical Huttinger Medizintechnik GmbH
Assigned to LASER-MEDIZIN-ZENTRUM GGMBH BERLIN reassignment LASER-MEDIZIN-ZENTRUM GGMBH BERLIN ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BERLIEN, HANS-PETER, BEUTHAN, JURGEN, MULLER, GERHARD, PHILIPP, CARSTEN
Assigned to CERAMOPTEC GMBH reassignment CERAMOPTEC GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LASER-UND-MEDIZIN TECHNOLOGIE GMBH, LAZER-MEDIZIN-ZENTRUM GMBH
Assigned to LASER-UND MEDIZIN TECHNOLOGIE GGMBH, BERLIN reassignment LASER-UND MEDIZIN TECHNOLOGIE GGMBH, BERLIN CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: LASER-MEDIZIN ZENTRUM GGMBH, BERLIN
Assigned to CERAMOPTEC GMBH, HUTTINGER MEDIZINTECHNIK GMBH & CO KG reassignment CERAMOPTEC GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LASER- UND MEDIZIN-TECHNOLOGIE GGMBH
Publication of US6039728A publication Critical patent/US6039728A/en
Application granted granted Critical
Assigned to BIOLITEC PHARMA MARKETING LTD. reassignment BIOLITEC PHARMA MARKETING LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BIOLITEC, INC.
Assigned to BIOLITEC, INC. reassignment BIOLITEC, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CERAMOPTEC INDUSTRIES, INC.
Assigned to BIOLITEC UNTERNEHMENSBETEILIGUNGS II AG reassignment BIOLITEC UNTERNEHMENSBETEILIGUNGS II AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BIOLITEC PHARMA MARKETING LTD.
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2255—Optical elements at the distal end of probe tips
    • A61B2018/2261—Optical elements at the distal end of probe tips with scattering, diffusion or dispersion of light

Definitions

  • the invention relates to a working shaft for photo-thermal therapy as well as a device for executing the method of photo-thermal therapy.
  • optical fibers and catheter systems It is known from to transmit optical rays via optical fibers and catheter systems into the interior of a body, wherein the optical fibers are each provided with suitable scatter bodies.
  • a working shaft is known from DE-C-35 12 018, wherein a fluid is used for cooling and as the waveguide.
  • impermissible heating occurs in the immediate vicinity of the distal end of the working shaft, which can constitute impermissible impairments.
  • a working shaft system which includes a working shaft for insertion into a working tube of at least one of an endoscope and a catheter.
  • the working shaft has a distal end defining a distal area in a vicinity thereof, and further includes: a device for radiating optical beams through the distal end; and a fluid for scattering the beams at least in the distal area.
  • the fluid is operatively associated with the device for radiating such that, at least in the distal area, a path of the beams extends inside the fluid, the fluid further being effective as a coolant for removing waste heat generated by a scattering of the beams in the distal area.
  • the invention is based on the realization that the possibilities of use of photo-chemical and photo-thermal reactions, which can be triggered and controlled in the interior of the body in a simple manner by means of endoscopy and catheter systems which are today common in the market place, can be considerably improved if a fluid is provided between the area of emergence of the beam and, from an optical waveguide and a dome.
  • the fluid is transparent to the beam, at the distal end of the working shaft, on the one hand, takes up the function of scattering the beam in the sense of evening the beam out in order to prevent too great a beam concentration in the impact area, and, on the other hand, makes possible local heat dissipation in the immediate vicinity of the distal end.
  • the dimensions of the cross section of the working shaft are limited for reasons of insertability, so that therefore the center of the beam must also be concentrated in a relatively small area.
  • the end area of the shaft is expandable, so that an increase in the surface of the area of emergence accessible to cooling can also be achieved.
  • a non-directional diffuse illumination which, however, is homogenized, is present at the place of application, which can be arbitrarily concentrated in one or several predetermined spatial directions or deflected into these directions and can be produced by elements determining the direction of the beam--such as can be provided by a predetermined design of the emergence or reflection surfaces located in the area of the distal end.
  • an optical beam in the wave length range between 400 nm to 1400 nm.
  • the most diverse appropriate physical scattering mechanism in fluids are to be considered for the execution of the invention.
  • a second optical shaft is pushed forward beyond the working tube of an endoscope, which at the distal end has a dome of a special shape sealed against fluids but optically transparent, wherein the shape in combination with the scattering properties of the dome materials is selected in such a way that predetermined volumetric elements can be sufficiently charged isotropically with optical radiation.
  • opalescent materials in crystal as well as glass form are particularly suited for light scattering, particularly when an ND:YAG or diode laser is employed.
  • the beam is preferably guided by an optical fiber waveguide to a proximal optical interface of the endoscope and inside the endoscope to the distal end by means of a suitable optical relay device.
  • the optical relay device is designed in such a way that the distally attached light-scattering dome is illuminated as homogeneously as possible.
  • the energy-transferring optical fiber is also continued inside the endoscope shaft, depending on the size of the endoscope system, as far as the distally attached light-scattering dome.
  • the numerical aperture of the optical fiber must be adapted to the desired solid angle.
  • the entire light-scattering tube inserted into the working tube of an endoscope is washed by a fluid to prevent heating of the applicator itself by vagrant stray light from the laser beam.
  • a light-scattering fluid such as an oil-water emulsion
  • an ultrasonic bath from silicon oil and water (mixed with suitable dispersants, if required)
  • a recirculating pump is also used as a cooling medium and is then coaxially directed through the endoscope shaft via a recirculating pump, wherein it is possible to adjust the scattering properties of the oil-water emulsion over a wide range by means of the frequency and intensity of the ultrasonic bath, so that it is possible in this manner to change the emission characteristics at the distal end of the optical scattering tube in a predeterminable way.
  • a flexible catheter hose is used in place of the rigid optical scattering tube which, in place of the optical scattering dome, has an expandable closure cap at the distal end which is transparent to the active radiation employed and does not absorb this radiation.
  • a bio-compatible scattering fluid for example a fat/oil-water emulsion, then also again flows--in the manner of an infusion solution--through this catheter hose closed off in this manner (as in the above cited example of the rigid scattering tube).
  • the laser beam is guided through a regular optical fiber, wherein the optical fiber sends the radiation into the expandable closure cap at the end of the catheter hose.
  • the closure cap preferably has a fill volume of typically 0.5 to 2 cm 3 --depending on the model--and in the expanded state has a length of typically 5 to 2 mm, which is also adapted to the intended field of employment.
  • the diameter in the expanded state can vary between the diameter of the catheter hose and approximately 1 cm.
  • the closure cap itself is made of a shape-retentive, only limitedly elastic plastic material in order to assume a radially-symmetrical configuration in the expanded state.
  • the expansion state of the closure cap is controlled by means of a pressure control at the inlet side of the cooling and scattering fluid. Because of the option of expanding the distal end area, the cooled close-in area is increased and in this way the danger of local overheating is additionally counteracted.
  • the increase in viscosity caused by cooling of the scattering fluid prevents a sufficient rinsing effect and thus cooling output at the tip of the working shaft.
  • the basic problem has essentially been solved in another advantageous further development of the invention also in that a low-boiling fluid or a gas which can be condensed at low pressure is used as the cooling fluid in such a way that this fluid is introduced into the optical working shaft either coaxially or periaxially to the fiber conducting the laser light and that the thermodynamic characteristic numbers of the fluids are selected in such a way that the fluid spontaneously vaporizes in the form of an aerosol, and by means of this vaporization process already removes vaporization heat from the vicinity of the distal end of the optical working rod whereby a cooling effect is generated.
  • a simultaneous activation of the laser beam then causes the complete vaporization of the aerosol, which results in a further cooling effect.
  • such a low-boiling fluid or condensed gas has the property to have a low viscosity even with low temperatures, possibly even below freezing.
  • Recirculation has the further advantage that it takes place only in the gaseous state, so that even with small dimensions of an optical working shaft flow resistance is practically completely prevented while at the same time cooling efficiency is increased.
  • any other low-boiling fluid such as certain alcohols or easily condensed gases, such as ethane, butane, etc. are preferably considered as cooling and scattering media.
  • An expandable end of the working shaft makes possible, in addition to the photo-thermal treatment, the application of pressure, particularly in connection with vascular applications.
  • the transparency of the tissue is increased by its expansion, so that the accessible treatment area is increased. Because pores are provided, fluid can get between the front surface of the distal end of the working shaft and the adjoining tissue, so that local overheating there is prevented.
  • FIGS. 1a to c three advantageous embodiments of the light-scattering shaft for use with an endoscope with a cylindrically rounded scattering dome, conical or mirrored on one side,
  • FIGS. 1d and 1e two embodiments of the invention showing advantageous configurations of the waveguide
  • FIG. 2 a block diagram of a device for recirculating the cooling and light-scattering fluids
  • FIG. 3a a further embodiment of the invention with a flexible optical shaft
  • FIG. 3b a device corresponding to FIG. 2 for use with the embodiment of the light-scattering shaft of FIG. 3a,
  • FIG. 4a a further embodiment of the optical working shaft of the invention with a vaporizing fluid as the cooling and scattering fluid
  • FIG. 4b a simplified variant of the embodiment corresponding to FIG. 4a
  • FIG. 5a a block diagram of the basic representation of a first embodiment of an external condensation device for use with an optical working shaft corresponding to FIGS. 4a and 4b, and
  • FIG. 5b a variant of the exemplary embodiment of FIG. 5a.
  • the rigid optical shaft 1 illustrated in FIGS. 1a to c can be used in this form for insertion into the working tube of an endoscope.
  • the optical shaft 1 On its distal end, the optical shaft 1 has a transparent light-scattering dome 5, into which the optical waveguide 2 is guided via an insertion lock 12.
  • a scattering fluid 21 constituting the scattering and cooling fluid can be introduced in the direction of the arrow into the interior of the optical shaft via the inlet 3 and can recirculate in a jacket tube 11, coaxial to the outlet 4--also in the direction of the arrow
  • the light-scattering dome 5 can be cylindrically rounded (FIG. 1a), conical (51 in FIG. 1b) or provided with a lateral radiating direction (FIG. 1c) created by deflection through a window 52.
  • a mirror element 53 for the directed reflection of the active beam is provided in case of lateral radiation. It can be seen that the scattering and cooling fluid is directed from an area of the proximal end to the distal end, where it is charged with radiation via the optical waveguide 2.
  • the fluid acts scatteringly in such a way that the beam, which at first is only directedly available at the outlet end of the optical waveguide, after being scattered by optical means--as illustrated--can be directed into the most different directions for isotropic radiation, wherein the deflection or direction selection means can be designed in the most simple manner.
  • a lateral spatial direction selection can take place by simply turning the working shaft together with the mirror 53 from the proximal end.
  • the numerical aperture of the optical waveguide preferably is greater than 0.4.
  • the cooling fluid can be moved in one direction in its interior and in the other direction between the optical waveguide and the outer wall, so that no further separating wall is required.
  • FIG. 1d shows a shaft including a waveguide 2' having a stepped distal end 2a'
  • FIG. 1e is a view similar to FIG. 1d showing a shaft with a waveguide 2" having a tapered distal end 2a".
  • FIG. 2 shows a device for recirculating the cooling light-scattering fluid, which is homogenized in an ultrasonic mixer and reservoir 33 and is then directed via a thermostat 32, which is controlled by a temperature sensor in the return line 34, to a pump 31.
  • the secondary pressure of the pump can be controlled via a pressure control device 35 in the inlet line 3.
  • FIG. 3a A further preferred embodiment of the invention in the form of a flexible optical shaft as the light-scattering catheter is shown in FIG. 3a.
  • a flexible catheter hose 6 is provided, which is closed off at the distal end by means of an optically transparent, partially elastic, dimensionally stable diaphragm 7, into which preformed pores 71 have been drilled.
  • the optical waveguide 12 is again inserted into the optical shaft via a lock 12.
  • the cooling scattering fluid 21 is introduced via an inlet 3 into the catheter with at least two hollow channels and flows via the outlet 4 to the service devices.
  • the associated service devices are individually represented in FIG. 3b.
  • the run-off is first directed to a reservoir 36, is from there carried via a thermostat 32, which is controlled by means of a temperature sensor 34 in the return line, to a pressure pump 31, which in turn is controlled via a pressure control device 35 in the inlet 3.
  • FIG. 4a shows a further disposition of the optical working shaft, in which the fluid to be vaporized is introduced, coaxially to the laser-light-transmitting optical fiber 2 in a coaxial jacket body 11, into the distal end of the optical working shaft 1 and, because of the ambient or radiation-induced temperature at the distal end, is first vaporized into an aerosol 22.
  • the aerosol 22 vaporizes completely into a gas 22, which is supplied via an outlet connector to a condenser and is again supplied as a liquid to the process via an inlet connector.
  • FIG. 4b shows an arrangement which is simplified in comparison with the embodiment of FIG. 4a, in which the vaporization fluid 20 is brought forward to the distal end of the optical working shaft by means of a thin hose element 15. There the aerosol and gas formation again takes place, wherein the gas 23 being generated is again supplied via an outlet connector to an external condensation device.
  • FIG. 5a shows the basic representation of an external condensation device for the case of a low-boiling fluid which can either be condensed already at room temperature or with additional cooling in a condenser 37 and is then again supplied to the process as a fluid via a pump 31.
  • the operating point is controlled and adjusted via a pressure control device 35.
  • FIG. 5b shows a further exemplary embodiment of the arrangement in accordance with the invention for the case where a gas which was condensed under pressure is used as the scattering and cooling medium.
  • the gas is first compressed by means of a compressor 38 and then condensed in a condenser 37. Again, the operating point is adjusted by means of a pressure control device 35.
  • the optical waveguide 2 which guides the laser beam is embodied to taper step-wise--or in any other way--at the distal end and to have a dull surface.
  • This can preferably be achieved by dipping the optical waveguide, from which the protective coating has been removed, into an etching fluid and then to pull it out in steps.
  • a stepped cone with a dull surface is created at the end of the optical waveguide.
  • the scattering fluid adds to the non-directional distribution of the beam, which is also aided by the dulling of the surface of the transparent dome formed at the distal end. Its geometrical shape, however, represents the prerequisite for attaining a desired intensity distribution of the beam in the application area.
  • a body of a rigid or flexible optical shaft in accordance with the invention again can take place either by means of the working shaft of an endoscope mentioned at the outset or, during a non-endoscopic procedure, by means of a flexible catheter and the use of a trocar or a conventional lock, wherein in case of use in solid tissue it is first necessary to open the way to the location of application by means of a mandrin. Subsequently the light-scattering catheter is introduced in place of the mandrin and then the insertion instruments are pulled back far enough so that they are no longer in the actual range of the beam.
US08/313,256 1992-04-06 1993-04-02 Working shaft for photo-thermal therapy Expired - Lifetime US6039728A (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE4211526 1992-04-06
DE19924211526 DE4211526A1 (de) 1992-04-06 1992-04-06 Optischer Arbeitsschaft zur Photo-Thermotherapie
DE4237286A DE4237286A1 (de) 1992-04-06 1992-10-30 Verfahren und Vorrichtung zur Effizienzsteigerung eines optischen Arbeitsschaftes zur Photo-Thermotherapie
DE4237286 1992-10-30
PCT/DE1993/000321 WO1993019680A1 (de) 1992-04-06 1993-04-02 Arbeitsschaft für die photo-thermo-therapie

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US (1) US6039728A (de)
EP (1) EP0634909B1 (de)
DE (2) DE4237286A1 (de)
WO (1) WO1993019680A1 (de)

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DE4237286A1 (de) 1994-05-05

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